1. Field of the Invention
The present invention relates to a method for the protection of a human being against any health impairment as a result of the ingestion of the whole or parts of a transdermal therapeutic system (TTS). More specifically, the present invention relates to a method for the protection of a human being against any health impairments as a result of the ingestion of the whole or parts of a transdermal therapeutic system, comprising at least one pharmacologically active ingredient-containing, especially a pressure-sensitive adhesive layer and at least on active-ingredient-impermeable backing layer, and further comprising a substance, which does not interact with the pharmacologically active ingredient and is able to keep off a human being from said ingestion.
2. Description of the Prior Art
A series of transdermal therapeutic systems present an acute danger of undesired side effects if administered orally by a human being in order to extract a soluble active agent. This is true whether the system is a new one or a used one. For example, infants have a tendency to stick anything interesting into their mouths and to at least suck or chew on it. This cannot be avoided especially if children happen to attain access to such systems by chance, especially systems with a release liner.
Such incidents have not yet been known to occur, but the pharmaceutical authorities increasingly fear that they might and have therefore, in various instances, demanded childproof packages. Such childproof packages have, in fact, been developed in various embodiments. However, they do not protect a child from putting a TTS in his or her mouth once the package has been opened or if the child somehow gets hold of a used patch. Especially in the case of a TTS with active substances such as anesthetics, analgesics, tranquilizers, or psychopharmacological agents, an oral abuse can lead to serious health impairments. On the other hand, addicts could be tempted to extract such active agents from transdermal therapeutic systems by means of sucking or chewing.
It is known that drinkable ethyl alcohol can be denatured and then put on the market as a methylated spirit in order to keep off people to drink it. A corresponding treatment of pharmaceutical dosage forms, particularly transdermal therapeutic systems, on the other hand, has not yet been published.